BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TFNA FEM NAIL Ø11 125° L170 TIMO15

    MDR report key: 22115029 · Received May 30, 2025

    Report

    Report Number
    8030965-2025-05487
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    May 7, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    10886982096302
    PMA / PMN Number
    K160167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: ADDED: H4 H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY REVIEW (DHR): MANUFACTURING LOCATION: MONUMENT MANUFACTURING DATE: 25-OCT-2024 EXPIRATION DATE: 01-OCT-2034 PART NUMBER: 04.037.112S, 11MM/125 DEG TI CANN TFNA 170MM-STERILE LOT NUMBER: 39733P3 (STERILE) LOT QUANTITY: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE WITH BATCH NUMBER 39733P3. NO NONCONFORMITIES OR MANUFACTURING IRREGULARITIES HAVE IDENTIFIED RELATED TO THE COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN PASSING THE CEPHALIC SCREW, SURGEON PROCEEDED TO BLOCK IT AS INDICATED BY THE TECHNIQUE AND WE CHECKED THAT IT HAD BEEN BLOCKED, BUT IT CONTINUED ROTATING, THE SYSTEM DOES NOT BLOCK EVEN IF WE GIVE THE TORQUE WITH THE TORQUE SCREWDRIVER OF 6 NM. SURGEON REMOVED EVERYTHING FROM THE PATIENT AND CHECKED THE NAIL ON THE SURGICAL TABLE AND SEE THAT IT DOES NOT ALLOW A CORRECT BLOCK EITHER. ANOTHER NAIL WAS PASSED TO THE TABLE SINCE THE OTHER ONE PRESENTED FAULTS IN THE CEPHALIC BLOCKING SYSTEM, AND PROCEEDED TO FINISH THE OSTEOSYNTHESIS PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9808 TFNA FEM NAIL Ø11 125° L170 TIMO15 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 39733P3 10886982096302

    Patients

    Seq Age Sex Outcome Treatment
    1 102 YR Female